Double-blinded, Randomized, Adaptive Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices (Attune™ and Cerena™) as Interventions for Physical and Emotional Health in Adjunctive Oncology Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 26
- 主要终点
- Cancer-related symptoms of anxiety (1)
研究概览
简要总结
This is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (SaMD) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial) oncology usual care regimens for up to 10 weeks.
Study population will consist of up to 553 participants with stage I-III breast cancer or stage I-III NSCLC. The primary endpoint is percent improvement in anxiety symptoms at Week 10 and secondary endpoints of percent improvement in depressive symptoms will be assessed at Week 12.
An interim analysis for efficacy and futility will be conducted once 236 participants have completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage I-III breast cancer or Stage I-III NSCLC who are currently in active treatment or have completed initial cancer directed treatments (surgery, radiation, chemotherapy) within the past 3 months;
- •Are experiencing at least moderate anxiety (GAD-7 >10) or mild-to-moderate depression (PHQ-8 score 5-11);
- •Are fluent in English; and
- •Have access to smartphone, or tablet capable of running iOS or Android software.
排除标准
- •Previous history of cancer;
- •<2-yr survival prognosis as determined by treating clinician;
- •Currently participating in investigative CBT trial for treatment of anxiety or depression;
- •Participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study;
- •Recently completed use of Blue Note Therapeutics Covid Cancer Care Program or other Blue Note Therapeutics-sponsored study; and
- •PHQ-9 Q9 response >0 AND Columbia Suicide Severity Risk Scale (or equivalent) score of Category 2- "suicidal ideation" at screening.
结局指标
主要结局
Cancer-related symptoms of anxiety (1)
时间窗: Baseline up to Week 10
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
次要结局
- Cancer-related symptoms of anxiety (2)(Baseline up to Week 12)
- Cancer-related symptoms of anxiety (3)(Baseline up to Week 10)
- Cancer-related symptoms of depression (4)(Baseline up to Week 12)
- Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients(Baseline up to Week 10)
- Cancer-related symptoms of depression (1)(Baseline up to Week 10)